GUEST CONTRIBUTORS

  • How To Prevent (Or Resolve) Communication Issues With Your CMO’s Project Manager
    How To Prevent (Or Resolve) Communication Issues With Your CMO’s Project Manager

    You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.

  • Is It Time For A Standardized CMC Knowledge Base?
    Is It Time For A Standardized CMC Knowledge Base?

    At small pharma companies, most of the CMC (chemistry, manufacturing, and controls) knowledge base is generated by a global array of outside providers.  The companies are challenged to create and manage a high-functioning knowledge base of information with little or no support staff. Let’s start with some examples of the current state.

  • Using Trending As A Tool For Risk-Based Thinking
    Using Trending As A Tool For Risk-Based Thinking

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.

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PHARMA OUTSOURCING WHITE PAPERS

Insights And Tips When Addressing Bioburden Challenges Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.

Challenges & Opportunities: Encapsulation Of Liquid & Semi-Solid Formulations Into Oral Capsules

The encapsulation of liquids and semi-solids provides solutions for convenient delivery through improved oral absorption of poorly water-soluble drugs.

Managing Risk In Biomanufacturing

Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

5 Steps To Optimizing Cost And Performance In Temperature-Controlled Pharmaceutical Shipments

Important things come in packages of all sizes, especially in the world of temperature-controlled, pharmaceutical transport, where it is not uncommon for even the smallest shipment to have a far-reaching impact on researchers, manufacturers, healthcare providers and patients.

Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions

This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Purification Of A Miniature Recombinant Spidroin Protein Expressed In E. Coli Using ÄKTA™ pure

Recombinant miniature spidroin, RepCT, derived from the nursery web spider, Euprosthenops australis, was purified using protocols developed for ÄKTA pure chromatography system.

Ongoing Collaboration Aims To Accelerate Biosimilar Approval In China

As the global biosimilars market continues to grow, so do the complications. Biopharma companies are facing new challenges to reduce their risk and cost and achieve a faster time-to-market to stay competitive.

Rapid Development Of A Biosimilar Production Process Shows Dramatic Time Savings

This application note describes the rapid development of a production process for a biosimilar molecule expressed in E. coli. Screening of modern chromatography media for downstream purification was done either with small packed columns and an ÄKTA avant system or with PreDictor plates (96-well pre-filled filter plates).

Ready-To-Use Fluid Management Solutions For Chromatography Systems

A selection of fluid management components from GE Healthcare’s ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for four typical large-scale chromatography setups.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

1st International Validation Week September 26 - 29, 2017
İSTANBUL
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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